Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate

Phase 2

• Conditions: Neonatal Sepsis; Refractory Shock
• Interventions: Drug: Methylene Blue

• Registration Number: NCT04110418
• Lead Sponsor: Ain Shams University

Brief Summary

A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate

Detailed Description

The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing methylene blue versus terlipressin in treatment of preterm neonate with catecholamines resistant septic shock the outcome as regard elevation of mean arterial blood pressure will be measured within 72 hours

Study Timeline

• Study Start: 2019-02-19
• Status Verified: 2019-09
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-30
• Last Update Submitted: 2019-09-30
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-01
• Primary Completion: 2020-02-19
• Study Completion: 2020-02-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• diagnosis of Septic shock according to clinical sepsis score of Tollner and Hematologic Scoring System of Rodwell
• Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE >0.5 mcg/kg/min)
• consent form

Exclusion Criteria

• known case of G6pd deficiency
• Hx of drug allergy MB, NE, terlipressin
• Patients with severely impaired renal function.
• History of maternal drug intake of selective serotonin reuptake inhibitors,and Serotonin-Norepinephrine Reuptake Inhibitors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terlipressin Group (Group TP )	Methylene Blue	The active substance is terlipressin acetate. Each ampoule contains 1 mg of terlipressin acetate in 8.5 ml solution for injection. This is equivalent to 0.12 mg terlipressin acetate per ml. * The powder is to be dissolved in the enclosed solvent and slowly administered intravenously. Further dilution up to 10 ml with sterile isotonic sodium chloride solution is possible. * Store in a refrigerator at 2-8˚C. * Keep the ampoules in the outer carton in order to protect from light
Methylene Blue group (Group MB)	Methylene Blue	Methylene Blue is supplied in 1 ml or 10 mL single-dose ampules. Each 1 mL ampule contains 10 mg of methylene blue as a clear dark blue solution * Any unused product or waste material should be disposed of in accordance with local practice, * For administration to be diluted before use in a solution of 50 mL 5% Dextrose in Water (D5W) in order to avoid local pain, particularly in the paediatric population. Use the diluted solution immediately after preparation. * Do not mix with sodium chloride 9 mg/mL (0.9%) solution for injection, because it has been demonstrated that chloride reduces the solubility of methylene blue.

Primary Outcome Measures

Name	Time	Method
to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure	24hours	The time taken to reach adequate mean blood pressure; Reduction in the dosage of the standard inotropic support

Secondary Outcome Measures

Name	Time	Method
to assess the effect of intervention on survival	4 days	mortality rate

Trial Locations

Locations (1)

Neonatal Intensive Care Units (NICUs), Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt